跳至主要内容
临床试验/NCT01881854
NCT01881854已完成不适用

Cross Sectional Study of Sleep-wake and Melatonin Patterns in Patients Treated for Craniopharyngiomas Compared to Matched Controls

Rigshospitalet, Denmark0 个研究点目标入组 30 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
24h melatonin and cortisol concentrations

研究概览

简要总结

The hypothalamus is a part of the brain containing a number of nuclei with a variety of functions. It is central in the regulation of hormone secretion, sleep, and circadian functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian rhythms and sleep.

Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus indirectly. In general, they are locally aggressive invading crucial structures e.g. the hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls, craniopharyngioma patients have previously been reported with impaired quality of life, increased self-reported general and physical fatigue, increased daytime sleepiness, and increased prevalence of severe sleepiness

Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic nucleus and thereby melatonin secretion leading to disturbed circadian function causing clinical manifestations in terms of daytime sleepiness and fatigue.

The investigators aimed to assess the influence of craniopharyngiomas or their treatment on melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and sleepiness.

15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake patterns were characterized by two weeks of actigraphy recordings and sleep diaries. Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.

详细描述

The hypothalamus is a part of the brain containing a number of nuclei with a variety of functions. It is central in the regulation of hormone secretion, sleep, and circadian functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian rhythms and sleep.

Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus indirectly. In general, they are locally aggressive invading crucial structures e.g. the hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls, craniopharyngioma patients have previously been reported with impaired quality of life, increased self-reported general and physical fatigue, increased daytime sleepiness, and increased prevalence of severe sleepiness

Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic nucleus and thereby melatonin secretion leading to disturbed circadian function causing clinical manifestations in terms of daytime sleepiness and fatigue.

The investigators aimed to assess the influence of craniopharyngiomas or their treatment on melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and sleepiness.

15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake patterns were characterized by two weeks of actigraphy recordings and sleep diaries. Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients treated for former craniopharyngiomas
  • aged 18-70 years.

排除标准

  • insufficient substitution of pituitary hormone deficiencies within six months prior to inclusion
  • total blindness
  • clinically significant liver or renal disease
  • use of non-steroid anti-inflammatory drugs
  • beta-receptor antagonists
  • antidepressants that affect serotonin
  • active cancer
  • epileptic seizures
  • working night-shift
  • breast feeding
  • pregnancy,
  • alcohol or drug abuse

结局指标

主要结局

24h melatonin and cortisol concentrations

时间窗: 1 year

次要结局

  • actigraphy(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulla Feldt-Rasmussen

Professor, chief physician

Rigshospitalet, Denmark

相似试验

Sleep Wake and Melatonin Pattern in Craniopharyngioma | 临床试验